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Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Terminated

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Carbon ion radiotherapy (CIRT)

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Carbon Ion Therapy, Concurrent Chemoradiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Pathologically confirmed NPC
Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
Recurrence diagnosed more than 12 months after the initial course of IMXT
Age ≥ 18 and < 70 years of age
Karnofsky Performance Score ≥70
Willing to accept adequate contraception for women with childbearing potential
Ability to understand character and individual consequences of the clinical trial
Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
Presence of distant metastasis
Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
Pregnant or lactating women
Patients who have not yet recovered from acute toxicities of prior therapies
A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
Refusal of the patient to participate into the study

Sites / Locations

Shanghai Proton and Heavy Ion Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CIRT with concurrent chemo arm

Arm Description

Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Overall survival of all patients

Progression-free survival of all patients

Full Information

NCT ID

NCT02801487

First Posted

June 11, 2016

Last Updated

February 12, 2020

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT02801487

Brief Title

Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Official Title

Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual of patients.

Study Start Date

September 2015 (Actual)

Primary Completion Date

January 1, 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD in the setting of concurrent chemoradiotherapy. Participants will be treated with CIRT with escalating dose starting from 52.5GyE (2.5GyE/daily fraction) to potentially 62.5GyE (2.5GyE/daily fraction) along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD in the setting of concurrent chemoradiotherapy for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Carbon Ion Therapy, Concurrent Chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CIRT with concurrent chemo arm

Arm Type

Experimental

Arm Description

Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).

Intervention Type

Radiation

Intervention Name(s)

Carbon ion radiotherapy (CIRT)

Intervention Description

Five dose levels (52.5GyE, 55GyE, 57.5GyE, 60GyE, 62.5GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 62.5 GyE are safely delivered, the recommended dose (or 62.5 GyE) will be the prescribed dose in the Phase II part of the study. Ninety-five percent (95%) of the isodose line should cover the GTV+3~5mm.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin (40mg/m^2) monotherapy will be given weekly along with radiotherapy.

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Time interval from the start to 4 months after the completion of concurrent chemoradiotherapy

Secondary Outcome Measure Information:

Title

Overall survival of all patients

Time Frame

From the diagnosis of local recurrence of NPC, a median of 2 years

Title

Progression-free survival of all patients

Time Frame

Time Frame: From the completion of CIRT, a median of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -Pathologically confirmed NPC Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy Recurrence diagnosed more than 12 months after the initial course of IMXT Age ≥ 18 and < 70 years of age Karnofsky Performance Score ≥70 Willing to accept adequate contraception for women with childbearing potential Ability to understand character and individual consequences of the clinical trial Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy Presence of distant metastasis Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC Pregnant or lactating women Patients who have not yet recovered from acute toxicities of prior therapies A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years Refusal of the patient to participate into the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiade J Lu, MD

Organizational Affiliation

Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201315

Country

China

12. IPD Sharing Statement

Learn more about this trial

Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

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